The Philosophy Of Medical Industry

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Medical product in general could be a life-threatening if it is not made in a perfect environment. The philosophy of medical industry depends on the efficacy of the product and it’s effect directly to the human body. Accordingly, the governments, stakeholders, scientists and all people who are involved to the industry field needs a road map to guide them for a product without fault or adverse events might happen which resulting from the inadvertent errors. Therefore, the idea of quality has been started early to apply the optimum performance and reach the highest level of accuracy. For instance, the total quality management and its important rule for establishing an integrated approach for the industry and distribution areas. In the…show more content…
"C" in cGMP stands for "current" requiring companies and manufacturers to use recent technologies and systems that are up-to-date in order to follow the regulations and implementation that required a fusion of regulation and principles.
Relationship between QA, QC and GMP
The concepts of Quality Assurance (QA), GMP and Quality Control (QC) are related to each other. I will explain each one individually to get the main idea from this combination and clarify the resultant. “QA covers all matters, which individually or collectively influence the quality of a product. It is the sum total of the organized arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use”. In contrast, QC is part of GMP. It is concerned with sampling, specification and testing. Also, QC should be headed by an appropriately qualified and experienced person. The main purpose of QC is to ensure that the necessary and relevant tests are actually carried out and that no materials or products will be released for sale or supply, until their quality have been evaluated and judged to be satisfactory.
History of GMP:
THE 1930s and 1970s: In 1941 nearly 300 people were killed or injured by one company’s sulfathiazole tablets, a sulfa drug tainted with the sedative, phenobarbital. That incident caused FDA to revise manufacturing and quality control
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